CN216318382U - Middle ear anti-adhesion membrane - Google Patents
Middle ear anti-adhesion membrane Download PDFInfo
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- CN216318382U CN216318382U CN202120855239.2U CN202120855239U CN216318382U CN 216318382 U CN216318382 U CN 216318382U CN 202120855239 U CN202120855239 U CN 202120855239U CN 216318382 U CN216318382 U CN 216318382U
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Abstract
The utility model discloses a middle ear anti-adhesion membrane, which comprises a central support base material, an adhesive and an antibiotic layer which are uniformly coated on two sides of the central support base material, and an outer polylactic acid-glycolic acid copolymer membrane which is bonded outside the adhesive and the antibiotic layer, wherein antibiotics are loaded on the surface of the polylactic acid-glycolic acid copolymer membrane. The ear anti-adhesion membrane is properly cut according to the specific conditions of a patient in clinical use, so that the injured tissue and the normal serosa can be isolated, the adhesion between the regenerated tissue and other surrounding normal serosa in the healing process of a wound is avoided, the ear anti-adhesion membrane can replace the tympanic membrane to transmit sound to a certain extent, and the problem of secondary injury caused by the fact that the cartilage tissue is taken from the body and placed in the ear anti-adhesion membrane is avoided.
Description
Technical Field
The utility model belongs to the technical field of medical material structures, and particularly relates to a middle ear anti-adhesion membrane.
Background
As a common clinical phenomenon, post-otic surgery adhesions can lead to serious clinical complications, such as adhesive otitis media, secretory otitis media, tympanopathy, etc., increasing the difficulty of re-surgery and the potential risk of developing further complications. Adhesions are often associated with post-surgical procedures, often in tissue repair procedures when separate tissue surfaces adhere together, and can be interpreted as an adhesion between tissue and organ, a postoperative complication when the adhesion affects normal tissue function. At present, no mature product special for preventing middle ear from adhesion in operation at home and abroad is seen, and only 6 clinical research reports related to the tympanic support sheet made of the silica gel material show that although the silica gel support sheet provides positive conditions for ossicular chain reconstruction, the number of samples is too small, and an exact conclusion is difficult to draw.
In addition, chinese patent CN109568298A discloses a middle ear anti-adhesion drug sustained release system, which comprises a membrane, a coating coated on the surface of the membrane, and a drug loaded in the membrane and the coating. Preferably, the membrane is a poly (lactide-co-glycolide) membrane. Preferably, the coating is a coating formed from a poly (lactide-co-glycolide) and polyethylene glycol. However, the middle ear anti-adhesion drug sustained release system has the following defects: 1) the degradation of the membrane may cause secondary adhesion at the affected part; 2) part of the population has allergic phenomena to polyethylene glycol.
SUMMERY OF THE UTILITY MODEL
The utility model aims to solve the first technical problem of providing a middle ear anti-adhesion membrane which is properly cut according to the specific condition of a patient in clinical use. The middle ear anti-adhesion membrane can not only isolate the injured tissue from the normal serosa, avoid the adhesion of the new tissue and other surrounding normal serosa in the healing process of the wound, but also play a role in replacing the tympanic membrane to a certain extent to transmit sound, and avoid the problem of secondary injury caused by the implantation of the cartilage tissue of the body; in addition, the anti-adhesion membrane fills partial space of the middle ear chamber, so that the change of the internal air pressure is not obvious, and the amplitude and the frequency of the pressure fluctuation of the middle ear chamber after operation can be further reduced; the outermost antibiotic can eliminate inflammation of the wound at the early stage of healing, and along with the prolonging of time, the polylactic acid-glycolic acid copolymer membrane is gradually degraded and metabolized by a human body, and the antibiotic at the inner layer can also play a role in secondary inflammation diminishing, so that inflammation and pathological changes of contacted tissues are avoided, and the anti-adhesion effect of the middle ear anti-adhesion membrane is improved.
For solving the first technical problem, the utility model adopts the following technical scheme:
a middle ear anti-adhesion membrane, comprising:
the center support base material is used for supporting the base material,
adhesive and antibiotic layers uniformly coated on both sides of the center support base material, an
An outer layer of polylactic acid-glycolic acid copolymer membrane adhered outside the adhesive and the antibiotic layer, and
and antibiotics are loaded on the surface of the polylactic acid-glycolic acid copolymer membrane.
In one embodiment, the central support substrate of the middle ear anti-adhesion membrane is made of one or more of polyetheretherketone, silicone, thermoplastic polyurethane rubber, and bacterial cellulose membrane.
As an embodiment, the middle ear anti-adhesion membrane is characterized in that: the mass ratio of the central support base material to the adhesive to the polylactic acid-glycolic acid copolymer membrane to the antibiotics is 70-95%: 0.5-1%: 3-29%: 0.5 to 1 percent.
As an embodiment, the middle ear anti-adhesion membrane is characterized in that: the central support base material accounts for 50-90% of the whole thickness and is rectangular, circular or polygonal.
As an embodiment, the middle ear anti-adhesion membrane is characterized in that: the adhesive is one or two of genipin and chitosan.
As an embodiment, the middle ear anti-adhesion membrane is characterized in that: the concentration of the adhesive is 0.5-5 wt%, and preferably 3 wt%.
As an embodiment, the middle ear anti-adhesion membrane is characterized in that: the antibiotic is one or more of vancomycin, erythromycin, tetracycline and aureomycin.
As an embodiment, the middle ear anti-adhesion membrane is characterized in that: the concentration of the antibiotic is 0.5-5 wt%, and preferably 3 wt%.
As an embodiment, the middle ear anti-adhesion membrane is characterized in that: firstly, coating adhesives on two sides of a central support base material and then coating antibiotics, or coating the antibiotics on two sides of the central support base material and then coating the adhesives, or coating the adhesives and the antibiotics on two sides of the central support base material after uniformly mixing the adhesives and the antibiotics.
As an embodiment, the middle ear anti-adhesion membrane is characterized in that: the shapes of the outer layer polylactic acid-glycolic acid copolymer membrane and the central support base material are consistent, and the membrane area is 0.1-1.5 square centimeters, preferably 1 square centimeter.
The utility model discloses a preparation method of the middle ear anti-adhesion membrane, which comprises the following steps:
1) taking the adhesive and the antibiotic according to the requirements of parts, then preparing the adhesive and the antibiotic into a solution with the concentration of 0.5-5 wt%, and fully stirring the solution into a uniform solution;
2) coating the uniform solution obtained in the step 1) on two sides of a central support substrate in sequence, then coating a polylactic acid-glycolic acid copolymer membrane, and carrying out forced air drying at 37-60 ℃ for 0.5-24 h to obtain a semi-finished product;
3) coating antibiotics on the outer surface of the semi-finished product obtained in the step 2) again to obtain the anti-ear adhesion membrane.
Any range recited herein is intended to include the endpoints and any number between the endpoints and any subrange subsumed therein or defined therein.
The starting materials of the present invention are commercially available, unless otherwise specified, and the equipment used in the present invention may be any equipment conventionally used in the art or may be any equipment known in the art.
Compared with the prior art, the utility model has the following beneficial effects:
the utility model provides an anti-adhesion membrane for middle ear, which is cut properly according to the specific condition of a patient in clinical use, can isolate injured tissues from normal serosa, and avoids the adhesion of newly-born tissues and other surrounding normal serosa in the healing process of wounds; the function of sound transmission by replacing the tympanic membrane per se can be achieved to a certain extent, and the problem of secondary damage caused by taking cartilage tissues from the body and placing the cartilage tissues in the body is avoided; partial space of the middle ear chamber can be filled, so that the change of internal air pressure is not obvious, and the amplitude and frequency of pressure fluctuation of the middle ear chamber after operation are further reduced; the outermost antibiotic can eliminate inflammation of the wound in the early stage of healing; along with the prolonging of time, the polylactic acid-glycolic acid copolymer membrane is gradually degraded and metabolized by a human body, and at the moment, the antibiotics in the inner layer can play a secondary anti-inflammation role, so that the inflammation and pathological changes of the contacted tissues are avoided, and the anti-adhesion effect of the middle ear anti-adhesion membrane is improved.
Drawings
The following detailed description of embodiments of the utility model is provided in connection with the accompanying drawings
FIG. 1 is a front view of an ear anti-adhesion membrane of the present invention.
Detailed Description
In order to more clearly illustrate the utility model, the utility model is further described below in connection with preferred embodiments. It is to be understood by persons skilled in the art that the following detailed description is illustrative and not restrictive, and is not to be taken as limiting the scope of the utility model.
It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.
It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship indicated in the drawings that is solely for the purpose of facilitating the description and simplifying the description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and is therefore not to be construed as limiting the utility model.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
As one aspect of the present invention, the present invention is a middle ear anti-adhesion membrane comprising:
the center-support base material 1 is supported,
adhesive and antibiotic layers 2 uniformly coated on both sides of the center support base material 1, an
An outer layer of polylactic acid-glycolic acid copolymer membrane 3 which is bonded outside the adhesive and antibiotic layer 2, and
and antibiotics 4 are loaded on the surface of the polylactic acid-glycolic acid copolymer membrane 3.
In some embodiments, the mass ratio of the center-support substrate, the adhesive, the polylactic-co-glycolic acid membrane and the antibiotic is 70-95%: 0.5-1%: 3-29%: 0.5 to 1 percent. In some embodiments, the center support substrate comprises 50-90% of the overall thickness and is rectangular, circular, or polygonal in shape.
In some embodiments, the adhesive is one or both of genipin and chitosan.
In some embodiments, the adhesive concentration is 0.5 to 5 wt%, preferably 3 wt%.
In some embodiments, the antibiotic is one or more of vancomycin, erythromycin, tetracycline, chlortetracycline.
In some embodiments, the concentration of the antibiotic is 0.5 to 5 wt%, preferably 3 wt%.
In some embodiments, the adhesive and the antibiotic layer are formed by coating the adhesive on both sides of the central support substrate and then coating the antibiotic, or by coating the antibiotic on both sides of the central support substrate and then coating the adhesive, or by uniformly mixing the adhesive and the antibiotic and then coating the adhesive and the antibiotic on both sides of the central support substrate.
In some embodiments, the outer polylactic acid-co-glycolic acid membrane sheet conforms to the shape of the central support substrate.
The utility model relates to a preparation method of the middle ear anti-adhesion membrane, which comprises the following steps:
1) taking the adhesive and the antibiotic according to the requirements of the parts, then preparing the adhesive and the antibiotic into a solution with the concentration of 0.5-5 wt%, and fully mixing and stirring the solution into a uniform solution;
2) coating the uniform solution obtained in the step 1) on two sides of a central support substrate in sequence, then coating a polylactic acid-glycolic acid copolymer membrane, and carrying out forced air drying at 37-60 ℃ for 0.5-24 h to obtain a semi-finished product;
3) coating antibiotics on the outer surface of the semi-finished product obtained in the step 2) again to obtain the anti-ear adhesion membrane.
Example 1
A middle ear anti-adhesion membrane comprising:
the center-support base material 1 is supported,
adhesive and antibiotic layers 2 uniformly coated on both sides of the center support base material 1, an
An outer layer of polylactic acid-glycolic acid copolymer membrane 3 which is bonded outside the adhesive and antibiotic layer 2, and
and antibiotics 4 are loaded on the surface of the polylactic acid-glycolic acid copolymer membrane 3.
The central support base material is made of polyether-ether-ketone material;
the thickness of the central support base material accounts for 50% of the whole thickness, and the shape of the central support base material is rectangular;
the adhesive coated on the two sides of the central support base material is genipin;
the antibiotics coated on the two sides of the central support substrate are vancomycin;
the adhesive with the concentration of 0.5 wt% is uniformly coated on two sides of the central support base material;
the concentration of the antibiotic is 0.5 wt%, and the antibiotic is uniformly coated on two sides of the central support base material;
the coating sequence of the adhesive and the antibiotic is that the adhesive is coated firstly and then the antibiotic is coated;
the polylactic acid-glycolic acid copolymer membrane is rectangular;
the antibiotic coated outside the polylactic acid-glycolic acid copolymer membrane is vancomycin;
the area of the middle ear anti-adhesion membrane is 1 square centimeter.
The preparation method of the middle ear anti-adhesion membrane comprises the following steps:
1) respectively taking antibiotics and adhesives according to the weight ratio of 1:1, then preparing the antibiotics and the adhesives into 0.5 wt% solution, mixing the two solutions, and fully stirring the mixed solution into a uniform mixed solution;
2) sequentially coating the uniform adhesive solution and the uniform antibiotic solution obtained in the step 1) on a central support base material made of a polyether-ether-ketone material, then coating a polylactic acid-glycolic acid copolymer membrane, and carrying out forced air drying at 37 ℃ for 24 hours to obtain a semi-finished product;
3) and (3) performing secondary coating of antibiotics on the outer surface of the semi-finished product obtained in the step 2) to obtain the middle ear anti-adhesion membrane.
Example 2
A middle ear anti-adhesion membrane comprising:
the center-support base material 1 is supported,
adhesive and antibiotic layers 2 uniformly coated on both sides of the center support base material 1, an
An outer layer of polylactic acid-glycolic acid copolymer membrane 3 which is bonded outside the adhesive and antibiotic layer 2, and
and antibiotics 4 are loaded on the surface of the polylactic acid-glycolic acid copolymer membrane 3.
The central support base material is a mixed material of silica gel and a bacterial cellulose membrane;
the thickness of the central support base material accounts for 90% of the whole thickness, and the shape of the central support base material is circular;
the adhesives coated on the two sides of the central support substrate are chitosan;
the antibiotics coated on the two sides of the central support substrate are vancomycin and tetracycline;
the adhesive with the concentration of 5 wt% is uniformly coated on two sides of the central support base material;
the concentration of the antibiotic is 5 wt%, and the antibiotic is uniformly coated on two sides of the central support base material;
the coating sequence of the adhesive and the antibiotic is that the antibiotic is coated first and then the adhesive is coated;
the polylactic acid-glycolic acid copolymer membrane is circular in shape;
the antibiotic coated outside the polylactic acid-glycolic acid copolymer membrane is erythromycin;
the area of the middle ear anti-adhesion membrane is 1.5 square centimeters.
The preparation method of the middle ear anti-adhesion membrane comprises the following steps:
1) respectively taking antibiotics and adhesives according to the weight ratio of 2:1, then preparing the antibiotics and the adhesives into solutions with the concentration of 5%, mixing the two solutions, and fully stirring the two solutions into a uniform mixed solution;
2) sequentially coating the antibiotic homogeneous solution and the adhesive homogeneous solution obtained in the step 1) on a central support base material made of a silica gel material, then coating a polylactic acid-glycolic acid copolymer membrane, and carrying out forced air drying at 60 ℃ for 24 hours to obtain a semi-finished product;
3) and (3) performing secondary coating of antibiotics on the outer surface of the semi-finished product obtained in the step 2) to obtain the middle ear anti-adhesion membrane.
Example 3
A middle ear anti-adhesion membrane comprising:
the center-support base material 1 is supported,
adhesive and antibiotic layers 2 uniformly coated on both sides of the center support base material 1, an
An outer layer of polylactic acid-glycolic acid copolymer membrane 3 which is bonded outside the adhesive and antibiotic layer 2, and
and antibiotics 4 are loaded on the surface of the polylactic acid-glycolic acid copolymer membrane 3.
The central support base material is thermoplastic polyurethane rubber;
the thickness of the central support base material accounts for 75% of the whole thickness, and the shape of the central support base material is a polygon;
the adhesives coated on the two sides of the central support base material are genipin and chitosan;
the antibiotics coated on the two sides of the central support substrate are vancomycin, tetracycline, chlortetracycline and erythromycin;
the adhesive with the concentration of 3 wt% is uniformly coated on two sides of the central support base material;
the concentration of the antibiotic is 3 wt%, and the antibiotic is uniformly coated on two sides of the central support base material;
the coating sequence of the adhesive and the antibiotic is that the adhesive and the antibiotic are coated after being mixed;
the polylactic acid-glycolic acid copolymer membrane is polygonal in shape;
the antibiotics coated outside the polylactic acid-glycolic acid copolymer membrane are chlortetracycline and erythromycin;
the area of the middle ear anti-adhesion membrane is 0.5 square centimeter.
The preparation method of the middle ear anti-adhesion membrane comprises the following steps:
1) respectively taking antibiotics and adhesives according to the weight ratio of 1:2, then preparing the antibiotics and the adhesives into solutions with the concentration of 3%, mixing the two solutions, and fully stirring the two solutions into a uniform mixed solution;
2) coating the two sides of the center support base material made of thermoplastic polyurethane rubber with the uniform mixed solution obtained in the step 1), then coating a polylactic acid-glycolic acid copolymer membrane, and carrying out forced air drying at 45 ℃ for 12h to obtain a semi-finished product;
3) and (3) performing secondary coating of antibiotics on the outer surface of the semi-finished product obtained in the step 2) to obtain the middle ear anti-adhesion membrane.
Comparative example 1
Example 1 was repeated with the only difference that: the central polyetheretherketone membrane is replaced with a D-polylactic acid material, as a result of which: the degradation is fast, and the anti-adhesion effect is not obvious.
Comparative example 2
Example 1 was repeated with the only difference that: the central polyetheretherketone membrane is replaced with a poly (lactide-co-glycolide) material, with the result that: the degradation is fast, and the anti-adhesion effect is not obvious.
Comparative example 3
Example 1 was repeated with the only difference that: the central polyetheretherketone membrane is replaced with a polycaprolactone material, the result of which is: the degradation is fast, and the anti-adhesion effect is not obvious.
Comparative example 4
Example 1 was repeated with the only difference that: the central polyetheretherketone membrane is replaced with a polycaprolactone lactide copolymer material, resulting in: the degradation is fast, and the anti-adhesion effect is not obvious.
Comparative example 5
Example 1 was repeated with the only difference that: the central polyetheretherketone membrane is replaced by a combination of a poly (lactide-co-glycolide) and polycaprolactone, resulting in: the degradation is fast, and the anti-adhesion effect is not obvious.
From the results of comparative examples 1 to 5, it can be seen that the central support substrate of the ear anti-adhesion membrane of the present invention is preferably polyetheretherketone, which has non-degradable characteristics compared to the material used in CN109568298A of the prior art, and the two have significant differences.
Comparative example 6
Example 1 was repeated with the only difference that: the adhesive concentration is 0.05 wt%, and the antibiotic concentration is 0.05 wt%; the result is: weak adhesion or incomplete inflammation.
Comparative example 7
Example 1 was repeated with the only difference that: the concentration of the adhesive is 10 wt%, and the concentration of the antibiotic is 10 wt%; the result is: excessive adhesion or a large amount of antibiotic remains.
As can be seen from the results of comparative examples 6 to 7, when the adhesive concentration and the antibiotic concentration were less than 0.5 wt%, the results were: weak adhesion or incomplete inflammation. When the adhesive concentration and the concentration of antibiotics are higher than 5 wt%, the result is: excessive adhesion or a large amount of antibiotic remains. Therefore, on the basis of the materials selected by the application, the product of the utility model can be obtained by matching the concentrations and the percentages of the raw materials, so that the required result of the utility model can be obtained.
It should be understood that the above-described embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. Not all embodiments are exhaustive. All obvious changes and modifications which are obvious to the technical scheme of the utility model are covered by the protection scope of the utility model.
Claims (8)
1. A middle ear anti-adhesion membrane, comprising:
the center support base material is used for supporting the base material,
adhesive and antibiotic layers uniformly coated on both sides of the center support base material, an
An outer layer of polylactic acid-glycolic acid copolymer membrane adhered outside the adhesive and the antibiotic layer, and
and antibiotics are loaded on the surface of the polylactic acid-glycolic acid copolymer membrane.
2. A middle ear anti-adhesion membrane according to claim 1, wherein the central support substrate is made of one of polyetheretherketone, silicone, thermoplastic polyurethane rubber and bacterial cellulose membrane.
3. A middle ear anti-adhesion membrane according to claim 1, wherein: the mass ratio of the central support base material to the adhesive to the polylactic acid-glycolic acid copolymer membrane to the antibiotics is 70-95: 0.5-1: 3-29: 0.5-1.
4. A middle ear anti-adhesion membrane according to claim 1, wherein: the central support base material accounts for 50-90% of the whole thickness and is circular or polygonal.
5. A middle ear anti-adhesion membrane according to claim 1, wherein: the adhesive is one of genipin and chitosan.
6. A middle ear anti-adhesion membrane according to claim 1, wherein: the antibiotic is one of vancomycin, erythromycin, tetracycline and aureomycin.
7. A middle ear anti-adhesion membrane according to claim 1, wherein: the adhesive and antibiotic layer is formed by coating the adhesive on two sides of the central support base material and then coating the antibiotic, or is formed by coating the antibiotic on two sides of the central support base material and then coating the adhesive.
8. A middle ear anti-adhesion membrane according to claim 3, wherein: the shapes of the outer layer polylactic acid-glycolic acid copolymer membrane and the central support base material are consistent, and the membrane area is 0.1-1.5 square centimeters.
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| CN202120855239.2U CN216318382U (en) | 2021-04-23 | 2021-04-23 | Middle ear anti-adhesion membrane |
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| CN202120855239.2U CN216318382U (en) | 2021-04-23 | 2021-04-23 | Middle ear anti-adhesion membrane |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113081482A (en) * | 2021-04-23 | 2021-07-09 | 柏为（武汉）医疗科技股份有限公司 | Middle ear anti-adhesion membrane and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113081482A (en) * | 2021-04-23 | 2021-07-09 | 柏为（武汉）医疗科技股份有限公司 | Middle ear anti-adhesion membrane and preparation method thereof |
| CN113081482B (en) * | 2021-04-23 | 2024-02-27 | 柏为（武汉）医疗科技股份有限公司 | Middle ear anti-adhesion membrane and preparation method thereof |
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